(30 days)
The Micro Ace™ Advanced Micro Access System is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guidewire into the vascular system.
The Merit Micro Ace™ Advanced Micro Access System (hereafter referred to as Micro Ace™) provides access to the vascular system and facilitates the placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guide wire. The system is available in 4 French and 5 French sizes – and includes the coaxial introducer-dilator pair, a 21 gauge needle and a 0.018" (0.46mm) guide wire.
The introducer-dilator assembly that is included in each kit is 10 cm effective length. The system will be offered with optional guidewires:
• Some catalog codes will include a nitinol wire with platinum guide wire tips;
• Some catalog codes will be offered with a stainless steel wire with platinum guidewire tips.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Micro Ace™ Advanced Micro Access System." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on human-in-the-loop or standalone AI performance.
Therefore, the following information cannot be extracted from the provided text:
- No AI/Machine Learning Component: The prompt's questions (e.g., about AI assistance, standalone algorithm performance, training/test set ground truth, expert adjudication) are relevant to a medical device that incorporates AI or machine learning. The Micro Ace™ Advanced Micro Access System is a physical medical device (a vessel dilator for percutaneous catheterization) and does not appear to have any software or AI component described in this document. The term "algorithm" is not mentioned in the context of device performance.
- No "Acceptance Criteria" for AI/Software Performance: The document outlines the performance testing conducted to ensure the device functions as intended and is safe, but these are typical engineering and biocompatibility tests for a physical device, not performance metrics for an AI algorithm.
- No Human Reader Study: Since there's no AI component, there's no multi-reader multi-case (MRMC) comparative effectiveness study with human readers assisting with AI.
- No Training or Test Sets for AI: The concepts of training and test sets and ground truth establishment (expert consensus, pathology, outcome data) are specific to AI/ML model development and evaluation. These do not apply to the physical device described.
Instead, the document details the following for a physical medical device:
1. Acceptance Criteria and Reported Device Performance (Summary):
The document states that "All tested samples met pre-established performance criteria and were deemed acceptable." Specific numeric acceptance criteria are not provided in the text, nor are the detailed reported performance metrics for each test. The document lists the types of tests performed:
| Acceptance Criteria (Type of Test) | Reported Device Performance |
|---|---|
| Design Verification Studies | |
| Leak Test | Met pre-established criteria |
| Marker Band-to-Tip Length | Met pre-established criteria |
| Effective Use Length | Met pre-established criteria |
| Introducer OD | Met pre-established criteria |
| Introducer ID | Met pre-established criteria |
| Dilator Drag | Met pre-established criteria |
| Introducer Stiffness | Met pre-established criteria |
| Sheath Kink Force | Met pre-established criteria |
| Sheath Kink Distance | Met pre-established criteria |
| Tip Insertion Force | Met pre-established criteria |
| Sidewall Compression | Met pre-established criteria |
| Sheath Hub Tensile | Met pre-established criteria |
| Radiopacity | Met pre-established criteria |
| Design Validation Studies | |
| Clinician feedback following assessment of design changes | Deemed acceptable |
| Biocompatibility Studies | |
| Cytotoxicity Study ISO Elution Method | Met pre-established criteria |
| Intracutaneous Irritation Study | Met pre-established criteria |
| Sensitization ISO Guinea Pig Maximum Sensitization Test | Met pre-established criteria |
| Acute Systemic Toxicity Study in Mice | Met pre-established criteria |
| Pyrogen Study USP Rabbit, Material Mediated | Met pre-established criteria |
| Hemolysis Study Extract and Direct Material Contact | Met pre-established criteria |
| Partial Thromboplastin Time Assay with Comparison Article | Met pre-established criteria |
| Heparinized Blood Platelet and Leukocyte Count Assay | Met pre-established criteria |
| Complement Activation (SC5b-9) Assay with Comparison Article | Met pre-established criteria |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions that both 4F and 5F Micro Ace™ products were tested, and testing included sterile devices (following ethylene oxide processing) and aged devices. The exact numerical sample size for each test is not specified.
The data provenance is from Merit Medical Systems, Inc., the manufacturer. It is internal device testing, not patient data from a specific country or retrospective/prospective study in a clinical setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This question is not applicable as the studies relate to physical device performance testing (e.g., mechanical properties, biocompatibility), not the establishment of ground truth for diagnostic imaging or similar applications requiring expert consensus. "Clinician feedback" was part of design validation, but the number and qualifications of these clinicians are not detailed.
4. Adjudication Method for the Test Set:
Not applicable. This refers to consensus building among experts for tasks like image labeling, which isn't relevant to the described device testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This type of study is for evaluating diagnostic performance (often with AI assistance). The Micro Ace™ is a physical medical access system, not a diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. This refers to AI algorithm performance.
7. The Type of Ground Truth Used:
Not applicable in the context of diagnostic AI. The "ground truth" for this device's performance is determined by meeting pre-specified engineering and biocompatibility test standards (e.g., a specific tensile strength value, absence of cytotoxic effects).
8. The Sample Size for the Training Set:
Not applicable. There is no AI model or "training set" for this physical device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
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September 27, 2023
Merit Medical Systems, Inc. Garry Courtney Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095
Re: K232609
Trade/Device Name: Micro Ace™ Advanced Micro Access System Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator For Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: August 28, 2023 Received: August 28, 2023
Dear Garry Courtney:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Misti L. Malone -S
Misti Malone, PhD Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K232609
Device Name
Micro Ace™ Advanced Micro Access System
Indications for Use (Describe)
The Micro Ace™ Advanced Micro Access System is intended for percutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm) guidewire into the vascular system.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| GeneralProvisions | Submitter Name:Address:Telephone Number:Contact Person:Date Prepared:Registration Number: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 208-4583Garry A. Courtney08/28/20231721504 |
|---|---|---|
| Subject Device | Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Review Panel: | Micro Ace™ Advanced Micro Access SystemPercutaneous Catheterization SystemDilator, Vessel, for PercutaneousCatheterization2DRE870.1310Cardiovascular |
| Predicate Device | Trade Name:Classification Name:Premarket Notification:Manufacturer: | Merit MAK® (Mini Access Kit)Dilator, Vessel, for PercutaneousCatheterizationK031691Merit Medical Systems, Inc.This predicate has not been subject to a design-related recall. |
| Reference Device | K091584 (Submission that allowed for modifications to K031691 wherestainless steel wires and nitinol wires were modified to includepalladium tips). The K091584 submission did not obsolete the designwith platinum tips that was cleared with K031691. |
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| DeviceDescription | The Merit Micro Ace™ Advanced Micro Access System (hereafterreferred to as Micro Ace™) provides access to the vascular system andfacilitates the placement of a 0.035" (0.89mm) or 0.038" (0.97mm)guide wire. The system is available in 4 French and 5 French sizes –and includes the coaxial introducer-dilator pair, a 21 gauge needle and a0.018" (0.46mm) guide wire.The introducer-dilator assembly that is included in each kit is 10 cmeffective length. The system will be offered with optional guidewires:• Some catalog codes will include a nitinol wire with platinum guidewire tips;• Some catalog codes will be offered with a stainless steel wirewith platinum guidewire tips. |
|---|---|
| Indications forUse | There is no change in the Indications for Use Statement from thepredicate to the subject device.The Merit Micro Ace™ Advanced Micro Access System is intended forpercutaneous placement of a 0.035" (0.89mm) or 0.038" (0.97mm)guidewire into the vascular system. |
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The design and technological characteristics of the subject modified Micro Ace™ are substantially equivalent to those of the predicate Mini Access Kit (MAK). The subject device has the same basic design as the predicate device. The differences between the predicate MAK® device and the subject/modified Micro Ace™ device are as follows:
- The introducer sheath is changed from high-density polyethylene . (HDPE) sheath to a coiled design with a thermoplastic elastomer iacket:
- A marker band is added to the introducer sheath to aid visibility . when used under fluoroscopy.
The comparison between the subject and the predicate devices is based on the following:
- Same intended use ●
- . Same indications for use
- Same sterilization methods ●
- Same packaging scheme
- Same fundamental technology/principles of operation ●
- Similar material types ( all meet ISO 10993 biocompatibility ● requirements)
- . Equivalent design
No performance standards have been established under Section 514 of the Food. Drug and Cosmetic Act for these devices. Performance testing of the subject Micro Ace™ was conducted based on the risk analysis - and based on the requirements of the following international standard:
-
- ISO 10555-1:2013, Intravascular Catheters Sterile and single-use catheters - Part 1: General requirements.
-
- EN ISO 11070 2014/A1:2018, Sterile Single-Use Intravascular Catheter Introducers.
-
- ISO 10993-1:2018, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and FDA guidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices.
Comparison to Predicate Device
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Biocompatibility testing was conducted to assess the biocompatibility profile of the finished device because a new material is used in the construction of the coiled sheath. Because the sheath is a patient-contacting component, the appropriate tests were performed for the classification: Externally Communicating Device with Circulating Blood Contact for a Limited Duration (≤ 24 hours).
-
- ISO 14971:2019, Medical Devices Application of Risk Management to Medical Devices.
This standard is referenced because the Special 510(k) is submitted with the recognition that a declaration of conformity to design controls is required, and to effectively utilize design controls and prepare the submission, a risk assessment is required to better understand potential risks that might be associated with product modifications - and then conduct appropriate verification and validation testing to support those modifications.
- ISO 14971:2019, Medical Devices Application of Risk Management to Medical Devices.
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The tests listed below were performed to demonstrate that the modified device meets product specification criteria, and to demonstrate there were no unacceptable risks associated with the changes made to the device.
The tests were performed on both 4F and 5F Micro Ace™ products. Further, the testing was performed on sterile devices (following ethylene oxide processing) and aged devices. All samples were manufactured in accordance with existing and validated processes, and when sterile, are representative of product that Merit Medical intends to commercialize.
All tested samples met pre-established performance criteria and were deemed acceptable.
Design Verification Studies
- Leak Test .
- Marker Band-to-Tip Length ●
- Effective Use Length .
Safety &
- Introducer OD . Introducer ID .
- Dilator Drag ●
- Introducer Stiffness ●
- Sheath Kink Force .
- Sheath Kink Distance ●
- Tip Insertion Force .
- Sidewall Compression .
- Sheath Hub Tensile .
- Radiopacity .
Design Validation Studies
- Clinician feedback following assessment of design changes. .
Biocompatibility Studies
- Cytoxicity Study ISO Elution Method .
- . Intracutaneous Irritation Study
- Sensitization ISO Guinea Pig Maximum Sensitization Test .
- Acute Systemic Toxicity Study in Mice .
- Pyrogen Study USP Rabbit, Material Mediated ●
- Hemolysis Study Extract and Direct Material Contact ●
- Partial Thromboplastin Time Assay with Comparison Article .
- Heparinized Blood Platelet and Leukocyte Count Assay .
- . Complement Activation (SC5b-9)Assay with Comparison Article
Performance: Verification. Validation and Biocompatibility
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| Summary ofSubstantialEquivalence | Based on the indications for use, design, materials, safety andperformance testing (verification and validation), and materials, thesubject Micro Ace™ Advanced Micro Access System is deemed to besubstantially equivalent to the predicate device, the MAK® (Mini AccessKit), K031691. Both the subject device and the predicate device arelegally manufactured by Merit Medical Systems, Inc. |
|---|---|
| ------------------------------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).